• Directly supported successful FDA 510(k) clearance, FDA Breakthrough Device Designation, and CE Mark regulatory approvals as an integral part of a small core team (less than 5 full-time employees), both major milestones and value drivers for a start-up medical device company• Lead developer of electrosurgical radiofrequency ablation devices throughout entire product lifecycle• Responsible for conceptualization, 3D CAD modeling, prototyping new designs, development and testing of product specifications, design transfer to manufacturing (DFM), design verification and validation (V&V), data analysis, risk management (FMEA), DHF documentation, process validation, and operations and manufacturing support• Manage multiple development projects simultaneously with collaboration from internal and external partners, considering time, scope, and cost • Establish and maintain design controls to support quality system audits and regulatory compliance, including direct experience in ensuring compliance with IEC/EN 60601 EMC & Basic Safety standards• Conduct pre-clinical human studies and GLP animal studies, including testing at clinical sites with prospective users, training physicians on the use of devices, protocol design, and data collection and analysis• Manage suppliers for off-the-shelf and custom components ensuring quality and compliance throughout the supply chain• Engage in COGS reduction projects, including design optimization, material cost reduction, critical chain, manufacturing process selection and optimization, design for assembly, and scrap reduction• Four published patents

• Supported early Phase I Conceptualization of a Class II “smart” programmable hydrocephalus shunting system, including development of DHF documentation and preliminary hazard analyses• Conducted primary research through development of user questionnaire and leading interviews with prospective users to inform technical requirements• Performed competitive device analyses to create initial market specifications and support predicate selection for regulatory approval through FDA 510(k) pathway• Conducted prior art search and patent publication review, and supported analyses of intellectual property space